This USDA issue paper, along with two others, were published in the Federal Register October 28, 1998 and are found on the USDA National Organic Program Web site at http://www.ams.usda.gov/nop/. The deadline for submission of public comment is December 14, 1998.
The Wallace Institute appreciates this opportunity to analyze options for implementation of the Organic Foods Production Act (OFPA). We support the Department's goal of clear, consistent regulations that stimulate the growth of organic markets, satisfy consumer expectations, and allow organic producers flexibility in making site-specific, real-time management decisions. Our response to the options presented in Issue Paper 2 is consistent with, and an expansion upon, the comments on the Proposed Rules for the National Organic Program submitted by the Wallace Institute on April 30, 1998.
Our comments will not respond to individual options outlined in Issue Paper 2. The multiple and conflicting interpretations of the options discussed at the October, 1998 NOSB meeting confused participants and USDA staff alike. Therefore, rather than qualify or condition our responses to specific options, we will use the important substantive issues they address as the focus for our recommendations.
While the options outlined in Issue Paper 2 for antibiotic and parasiticide use treat these two categories of animal medications identically, we find substantial justification for evaluating them separately. The significant differences which exist in purpose of application, essentiality to organic systems, and consumer expectations merit the consideration of antibiotics and parasiticides as distinct categories of synthetic materials. While the NOSB had, in the past, made parallel recommendations concerning the use of antibiotics and parasiticides, the Board recognized clear distinctions between the two categories at the Ontario, California meeting in March, 1998.
Recommendations
DISCUSSION
Antibiotics
The role of antibiotics in animal production has long been controversial and limiting their use in organic operations was a priority in the OFPA. Section 6509(d)(1)(A) prohibits the use of subtherapeutic doses of antibiotics. Subsequent language in Section 6509(d)(1)(C) prohibits the administration of medicine, other than vaccinations, in the absence of illness. The OFPA does identify "livestock parasiticides and medicines", including antibiotics, as a category of material suitable for inclusion on the National List of approved synthetics. Synthetic materials placed on the National List can only be used for itemized, specified applications. The NOSB is responsible for identifying which synthetic materials are suitable for use in organic operations and the Secretary, before and after public comment, develops the National List by choosing from these recommendations.
Organic production must be an expression of, not an alternative to, the humane treatment of livestock and provide at least as much protection to animals as conventional systems do. It has always been the NOSB's position, which the Wallace Institute strongly supports, that an ill animal requiring antibiotics must receive the treatment to alleviate prolonged suffering and potential mortality. Just as a field which has been left fallow for years does not become "organic by neglect", an animal cannot become certified because it is denied a conventional treatment it requires. Certified livestock operations must adopt a pro-active approach to animal welfare and divert to conventional operations (and markets) those animals which are not sustained by organic care.
Reliance upon synthetic antibiotics in organic agriculture has evolved as producers acquire expertise in preventative management and alternative treatments. Innovators in organic livestock management have consistently found ways to reduce, even eliminate, their dependence on synthetic antibiotics. Driven by consumer demand which favors unqualified label claims ("no ... used", "never treated with..."), the organic livestock industry has been quick to adapt innovative techniques. The USDA has facilitated this trend by approving label claims such as "antibiotic and hormone free" which have become successful marketing devices. The pace of change has been so swift that the NOSB fundamentally re-wrote its recommendations for the use of antibiotics before the original position was four years old. By re-writing its recommendations on use of antibiotics, the NOSB demonstrated that meaningful standards need to respond to industry practice and consumer preference. In re-evaluating its position on antibiotics and parasiticides, the USDA should incorporate proven innovations in organic practice while leaving some flexibility for production areas where change has not been as conclusive.
In its initial recommendations from 1994 and 1995, the NOSB supported using the flexibility within OFPA to allow use of antibiotics in dairy and breeder stock under certain conditions and with extended withdrawal periods. In 1998, however, the Board eliminated these exceptions by recommending that "No animal product or animal by-product may be labeled as organic once an antibiotic has been given to the animal, except as provided for production stock under the Origin of Livestock Section 205.12." This recommendation means that once a certified animal is treated with antibiotics for any reason, none of its products can again be sold as organic. This position is far more stringent than the standard found in the USDA's Proposed Rules. The Section 205.12 exception pertains solely to the treatment of animals prior to their introduction to organic systems. While we support the NOSB's position, we do not favor extending the exemption to the category "Livestock used for the production of non-edible livestock products" created in Section 205.12(a)(4). In our comments of April 30, we stated that there is no statutory provision within OFPA to support differential treatment of animals based upon the nature of the products derived from them. The Wallace Institute continues to believe that creating this category and applying weaker standards will mean that affected animals will be inadequately integrated into the certified operation. The exception for antibiotic use prior to an animal's introduction to an organic operation should be determined by its species, not its market niche.
The NOSB was able to strengthen its standards on antibiotics because producers developed innovative ways to avoid using them. These innovations came through considerable effort; most producers agree that avoiding antibiotics requires highly sophisticated management techniques. Advances in understanding animal health care and the improved availability of replacement stock contributed to the NOSB's decision to revise its antibiotic use recommendation. Organic livestock producers have consistently demonstrated their ability to raise animals without using antibiotics. In instances when antibiotic use is deemed essential for survival, the treated animal can be diverted to the conventional market. Because certified replacement stock have become more widely available, a producer who loses capacity due to required treatments can efficiently rebuild his organic operation. Consumers are paying a price premium for animals products raised without antibiotics and the USDA should support this trend by adopting the NOSB's 1998 recommendation.
Apiculture is one important production system in which we suspect that alternatives to antibiotics are not yet fully developed. Use of antibiotics may be necessary and justifiable for the control of documented occurrences of American foulbrood in apiculture operations. We do not support prophylactic applications of antibiotics in instances where disease is not established. While apiaries should be regulated as livestock operations, beekeepers cannot exercise the same measure of control over their operations that other producers do. For example, beekeepers cannot monitor the source of their animals' food as producers of pastured animals can. Neither can beekeepers protect the hive by culling individual sick bees. We believe that organic operations which otherwise comply with their farm plan should be allowed an exception for the use of specific approved antibiotics in cases where foulbrood becomes established in the hive.
The Wallace Institute supports the initiative the organic industry and the NOSB have taken to restrict and, in cases, eliminate the approved uses of antibiotics in certified operations. We hope that the limited and conditional uses we support for production stock and in hives diagnosed with foulbrood are the exceptions that prove the rule. We endorse these exceptions because we do not believe that natural alternatives are viable and that the antibiotic treatments satisfy OFPA's requirements for allowable synthetics.
At this time, the Wallace Institute does not have sufficient information or expertise to determine whether the prohibition on the use of antibiotics should apply to aquaculture operations. It is possible that aquaculture operations may operate without antibiotics, just as organic livestock producers have refined their practices to eliminate them. It is also possible that specific applications of antibiotics will be as justifiable and unavoidable in aquaculture operations as we believe they are for the control of foulbrood. The NOSB has received minimal public input on this subject and there are few existing operations from which to learn. We need additional insight into current practice and the potential for innovation before reaching a conclusion on the use of antibiotics in these operations. We urge the USDA and the NOSB to solicit input from affected producers and consumer interests on this topic.
Parasiticides
Our analysis of organic livestock production indicates that producers have not been able to develop practices and treatments to replace parasiticides as they have for antibiotics. Without parasiticides, poultry and young sheep seem to be especially vulnerable to parasites. For the control of parasites, environmental conditions, including temperature and precipitation, may exist for which no level of management expertise can substitute for parasiticide use. In the absence of parasiticides, many organic pasture-based grazing systems may be impossible to maintain without excessive animal culling and mortality. Organic standards which have allowed conditional use of parasiticides essentially trade off use of a synthetic material for the multiple benefits (for the land as well as the animal) associated with grazing. The ability to pasture raise animals, especially poultry and sheep, is a significant potential benefit to weigh when considering the suitability of parasiticides in organic production systems.
On balance, the Wallace Institute supports the conditional use of parasiticides in organic livestock operations. We encourage the Department to incorporate into the next Proposed Rules the 1994 New Mexico NOSB recommendations for allowing the use of synthetic parasiticides. These recommendations are based on prevention of illness, biological controls, and culling of infected animals, and permit the use of parasiticides as a last recourse. Producers are allowed the discretion to use approved parasiticides, but their decision would be subject to certifier review of the farm plan. We expect that these procedures will result in a collaborative relationship where producers incrementally refine their management practices to reduce their dependence on synthetic materials.
The Wallace Institute also supports the NOSB recommendations on the handling of products from animals which have been treated with synthetic parasiticides. The NOSB proposed that animals which receive necessary treatment could not be sold as certified slaughter stock, but could be allowed as breeder and dairy stock after appropriate withdrawal periods. These provisions allow producers to provide humane treatment without preventing their animals from eventually returning to organic care. Allowing the conditional use of parasiticides rewards producers for maintaining organic systems without removing their final safety net during emergencies.
Producers should assess the need for parasiticides in their farm plan by providing a detailed analysis of their efforts to minimize exposure to parasites and what synthetic treatments they believe will be required. Given their understanding of regional conditions and the producer's past performance and compliance record, certifying agents can best determine if the suggested treatment regime is allowable. Dialogue during the certification process can insure that the quantity and duration of treatment are appropriate to the operation under prevailing regional conditions. Requiring producers to document their parasite management practices in a certifier-approved farm plan and establishing handling restrictions on treated animals will insure that synthetic treatments are the option of last resort. We find it relevant that the NOSB's 1994 recommendations on conditional use and post-treatment withdrawal periods were applicable to antibiotics as well as parasiticides. Producer innovation in organic livestock management has enabled the NOSB to amend its antibiotic recommendations in favor of more restrictive standards. We believe that the evolution of production practices, augmented by significant federally-supported research, could similarly achieve a pronounced reduction in the dependence on parasiticides in organic livestock operations.
OFPA's provisions for developing a National List of approved synthetics allows the NOSB and the Secretary to identify which parasiticides are allowable in organic systems. We strongly encourage the USDA to begin the necessary TAP review process to determine suitability of specific synthetic parasiticides. In addition, the ARS should dedicate resources to evaluating current organic production practices related to parasiticides and evaluate the conditions which most directly contribute to their use. We suspect that a better understanding of the susceptibility of particular species to disease (especially older breeds relative to modern hybrids developed for intensive production) as well as the climatic conditions which contribute to regional differences in the pressure from parasites will significantly advance the ability of organic producers to handle the problem appropriately.
Reflections on Public Comment and the Role of Animal Medications
The outpouring of negative public reaction to the livestock production provisions in the Proposed Rules has clearly affected the options put forward in this Issue Paper. Many comments adamantly rejected the provisions which the USDA proposed for synthetic medications but did not substantively address what role they thought they should have. The USDA has had to interpret many thousands of comments which did little more than denounce the proposed policy. This blanket criticism may have prompted the Department to raise the option of prohibiting the use of any medication in organic livestock production. Upon review of the statute, the historical debate on this subject, and the comments themselves, the Wallace Institute believes that a blanket prohibition on the use of medications is unwarranted. With regard to food safety and animal welfare, antibiotics and hormones have consistently been the medications of greatest concern to the general public. The OFPA specifically prohibits the use of hormones and growth promoters and sets very prescribed conditions on the use of antibiotics. Taken together, the ban on hormones and the stringent NOSB recommendations on antibiotics will go a long way towards allaying public concern about synthetic materials in organic operations.
OFPA allows, and concern for the animals dictates, that the NOSB evaluate every natural and synthetic medication on its own merits. Many natural treatments, including pro-biotic and homeopathic remedies, have a proven success record and are perfectly compatible with organic systems. The Secretary should not seek to prohibit any natural medication unless the NOSB has recommended that it be placed on the National List of prohibited natural materials. Similarly, as mandated by OFPA, the Secretary may elect to add synthetic medications to the National List of approved materials upon the NOSB's recommendation.
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